OIML G 21 • Guidance for defining the requirements for a certification system for prepackages

C.4 Assessment of compliance

Designated bodies should ensure that packers that they have certified fulfil the requirements by carrying out inspections of packers as required and issuing assessment reports after each visit. The following specific requirements for assessing compliance should be applied:

C.4.1

In the case of initial assessment by a designated body, packers should be subjected to at least the following:

  1. determination that the packer complies with the requirements of Annex A and has the necessary qualified personnel, facilities, measuring and test equipment, and control procedures to provide capability for ensuring compliance of prepackages to the stated requirements;

  2. determination of the suitability of the packer’s production system; and

  3. determination of the conformity of prepackages produced by the packer by means of reference testing.

C.4.2

In order to maintain certification the packer should, depending on the applicable scheme, be subject to:

  1. an assessment of the continued suitability and effectiveness of the packer’s production system at specified intervals not exceeding twelve months through inspection (including review of required process control records), testing of prepackages and, where applicable, witnessing the procedures required by the production system; and

  2. unannounced inspections, surveillance, and testing if necessary; or

  3. the implementation of more frequent or detailed inspections, surveillance, and testing when a need is indicated.